Tiziana Life Sciences Ltd (NASDAQ:TLSA) announced that it has submitted its seventh annual Development Safety Update Report (DSUR) to the US Food and Drug Administration (FDA), reporting no drug-related serious adverse events associated with intranasal foralumab after a cumulative exposure of 37.4 patient-years.
The DSUR covers the period from September 21, 2024, to September 2, 2025, and summarizes safety and tolerability data for intranasal foralumab, a fully human anti-CD3 monoclonal antibody being developed for neuroinflammatory diseases.
According to the company, the report includes data from studies and expanded access programs involving patients with non-active secondary progressive multiple sclerosis (naSPMS), multiple system atrophy, and Alzheimer’s disease.
Tiziana said the submission comes amid renewed attention on safety considerations in neuroinflammatory therapies following the FDA’s December 23, 2025, decision to issue a complete response letter denying approval of Sanofi’s tolebrutinib for non-relapsing secondary progressive multiple sclerosis, citing toxicity concerns.
“The FDA’s December 23, 2025, complete response letter denying approval of Sanofi’s tolebrutinib for nrSPMS, based on toxicity, highlights the need for a safe therapy for untreated neuroinflammatory disorders,” Tiziana CEO Ivor Elrifi said in a statement.
“We have seen 37.4 patient-years of cumulative foralumab exposure with no study drug-related serious adverse events, a milestone that reinforces the safety of our intranasal approach.”
The company said that the majority of the reported exposure, 30.7 patient years, came from an Expanded Access Program in which 14 naSPMS patients received intranasal foralumab at a dose of 50 micrograms per administration, given six days per three-week cycle, for treatment durations ranging from 23 weeks to 3.5 years.
An additional 5.2 patient-years of exposure were recorded in the TILS-021 randomized trial and its TILS-022 open-label extension, where naSPMS patients received either 50- or 100-microgram doses of intranasal foralumab.
The DSUR also included 0.5 patient-years of exposure from a single-patient expanded access program for moderate Alzheimer’s disease, in which the patient completed 28 weeks of treatment at a 50-microgram dose.
Tiziana said no serious adverse events were attributed to the study drug across these nasal administration studies.
Reported adverse events were described as consistent in type and frequency with those observed in prior reporting periods, and the company said no new safety risks were identified that would require significant changes to study protocols.
The company added that the safety profile observed with intranasal foralumab is consistent with earlier studies of foralumab administered intravenously in healthy volunteers and in patients with Crohn’s disease and kidney transplants.
Tiziana noted that, unlike intravenous administration of anti-CD3 monoclonal antibodies, which has been associated with infusion-related reactions, intranasal delivery of foralumab has not shown such effects. The company said no additional safety-related actions are required based on the latest DSUR.
The company expects results from its Phase 2 trial of intranasal foralumab in naSPMS in 2026.